Senior Director, Regulatory Affairs Strategy & BD&L

At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 associates we innovate fearlessly champion progress and act swiftly to impact global eye health. We foster an inclusive culture recognizing your contributions and offering opportunities to grow your career like never before. Together we make a difference in the lives of our patients and customers. Are you ready to join us

This role is part of Alcons Quality & Regulatory Affairs function a team that ensures our products are in compliance with global local and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Sr. Director Regulatory Affairs Strategy (Management Path) is primarily responsible for developing and driving strategies for Quality and Regulatory oversight of Alcon Affiliate sites in the LACAR Region. You will lead product registration maintain medical device licenses and ensure quality oversight while collaborating with global regulatory clinical and R&D teams.

Specifics Include:

• Lead multiple departments or a large division within the Regulatory Affairs team providing strategic leadership and ensuring compliance with regulatory requirements
• Leads preparation of global regulatory plans and product strategies for assigned products.
• Manage and provide regulatory support on business development and licensing activities that aligns with corporate strategy.
• Manage and participate in conducting regulatory due diligence activities.
• Direct the development and submission of product/process registrations progress reports supplements amendments and periodic experience reports
• Provide strategic product direction to teams interact and negotiate evidence requirements with regulatory agencies and ensure rapid and timely approval of products and their continued approval
• Advise development and commercial teams on new product development safety efficacy manufacturing changes product line extensions labeling and appropriate regulations and interpretations
• Oversee the execution and coordination of various regulatory affairs activities including product submissions renewals and updates by coordinating between plants agents and continuously communicating with all parties involved to ensure timely submission and approvals
• Provide regulatory strategies and risk assessments/mitigation for new product introductions and product changes maintaining regulatory compliance to drive competitive advantage
• Support products in either the medical device and/or pharmaceutical family of products ensuring adherence to all relevant regulations
• Lead strategic planning cross-functional collaboration advanced problem-solving and strong communication skills to impact multiple departments to ensure synergy across projects driving competitive advantage through strategic decision-making and the overall business outcomes
• Focus on talent development to enhance capabilities.
• Ensure all associates adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs) maintaining accurate and complete documentation ensuring rigorous quality control and completing all required training
• Contribute to the overall compliance of the organization and commit to continuous improvement in operations
• All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs) maintaining accurate and complete documentation ensuring rigorous quality control and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

What Youll Bring to Alcon

• Bachelors Degree
• The ability to fluently read write understand and communicate in English
• 12 Years of Relevant Experience
• 8 Years of Demonstrated Leadership
• Travel: Minimal

• Work Location: Onsite Fort Worth TX (This role may be based at other Alcon locations subject to business needs)
• Relocation Assistance/Sponsorship: None

How you can thrive at Alcon:

• Work together with colleagues to share standard methodologies and discoveries as work progresses.
• Discover your career in a fresh way through specific growth and development possibilities.
• Join Alcons mission to provide outstanding innovative products and solutions to improve sight improve lives and grow your career!
• Alcon provides a robust benefits package including health life retirement flexible time off for exempt associates PTO for hourly associates and much more!

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ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY

Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation marital or veteran status disability or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to and let us know the nature of your request and your contact information.